System Accuracy and Interference Evaluation of two Blood Glucose Meters for Patient Self-Testing (Wellion NEWTON and Wellion LEONARDO) – Clinical and Laboratory Trial Protocol in Accordance with ISO 15197:2015

System Accuracy and Interference Evaluation of two Blood Glucose Meters for Patient Self-Testing (Wellion NEWTON and Wellion LEONARDO) – Clinical and Laboratory Trial Protocol in Accordance with ISO 15197:2015 - MED-BGM-001

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031124

Enrollment

100

Registered

2023-01-20

Start date

2023-01-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus Type I and Type II

Interventions

Group 1: Healthy subjects and patients with type 1 or type 2 diabetes mellitus. Measurements of blood glucose for the test devices and the reference method are done with capillary blood from the finge

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Healthy subjects or patients with Type 1 or Type 2 diabetes mellitus • Subjects who are able to complete informed consent form (by him/herself or by his/her guardian) • 18 years old and above • HbA1c < 10% and hematocrit between 30-55% • Screening glucose values, which naturally fall into one of the distribution categories between 50 to 399 mg/dL

Exclusion criteria

Exclusion criteria: • Medical history of hypotonic reactions with unconsciousness during blood draws or venous cannula insertion. • Patients who have suffered from major cardiovascular events during the past 6 months. • Intake of xylose or mannose enriched meals • Pregnancy • Nursing mothers • Intake of ascorbic acid (vitamin C) of more than 1 gram per day within two days prior to blood collection • Repeated blood pressure measurements at the study site (if applicable, under the patient´s routine hypertensive medication) with values >165/95 mmHg (for diabetic patients undergoing glucose adjustment procedures only). • Patients with a history of clear and severe signs of hypoglycemic events at blood glucose levels below 60-70 mg/dL (for patients undergoing glucose adjustment procedures only). • Patients with a daily insulin dose of more than 80 IU and patients with strongly fluctuating daily insulin doses at the discretion of the investigator. • Patients without recognition of hypoglycemic events.

Design outcomes

Primary

Measure	Time frame
•Demonstrate accuracy of the Wellion NEWTON BGM and the Wellion LEONARDO BGM when measurements are done with capillary blood from the fingertip with 3 strip lots in comparison to the reference method •% readings = 15 mg/dL (= 0,8 mmol/L) for blood glucose values = 100 mg/dL (= 5,6 mmol/L) •% readings 100 mg/dL (> 5,6 mmol/L)	—

Secondary

Measure	Time frame
• Demonstrated system accuracy by means of the consensus error grid analysis (100 % in A and B) • Demonstrate MARD of the Wellion NEWTON and Wellion LEONARDO BGM	—

Countries

Germany

Contacts

Public ContactAndreas Pfützner

PSHI Praxis GmbH

info@pfuetzner-mainz.com004961315884640

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026